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February 10, 2012
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divalproex sodium enteric-coated tablet - oral, Depakote

GENERIC NAME: DIVALPROEX SODIUM ENTERIC-COATED TABLET - ORAL (dye-VAL-pro-ex SO-dee-um)

BRAND NAME(S): Depakote

Warning | Medication Uses | How To Use | Side Effects | Precautions | Drug Interactions | Overdose | Notes | Missed Dose | Storage

WARNING: This medication has rarely caused serious (sometimes fatal) liver problems. Children less than 2 years old are more likely to develop severe liver problems, especially if they have metabolic problems, severe seizures with mental retardation, brain disease (organic) or if they take more than one drug for seizures. If divalproex sodium is being used in patients with these conditions, then it should not be taken with additional anti-seizure medications. Liver function tests should be performed before and during treatment.

Early signs of serious liver problems include vomiting, unusual tiredness, swelling of the face or loss of seizure control in patients with seizure disorder. Tell your doctor immediately if you develop any of these symptoms.

This medication has rarely caused severe (sometimes fatal) disease of the pancreas (pancreatitis). This problem may occur at any time during therapy and may worsen quickly. Tell your doctor immediately if you experience stomach/abdominal pain, nausea, vomiting, and loss of appetite while taking this medication.

This medication can cause birth defects. Discuss the risks and benefits of this medication with your doctor, especially if it is prescribed for a condition other than seizure disorder (e.g., migraine headache).

USES: This medication is used to treat seizure disorders, certain psychiatric conditions (manic phase of bipolar disorder), and to prevent migraine headaches. It works by restoring the balance of certain natural substances (neurotransmitters) in the brain.OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This drug may also be used for other mental disorders (e.g., schizophrenia).

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking divalproex sodium and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Take this medication by mouth as directed by your doctor. You may take it with food if stomach upset occurs. Swallow the tablet whole. Do not crush or chew the tablet, which can irritate the mouth or throat.Dosage is based on your weight, medical condition, and response to therapy. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day to keep the amount of medication in your blood constant.If this medication is used for seizures, do not stop taking it without consulting your doctor. Your condition may become worse if the drug is suddenly stopped. Your dose may need to be gradually decreased.Divalproex sodium does not relieve acute migraine headaches. Take other medications as directed by your doctor for acute attacks.Inform your doctor if your condition does not improve.




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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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